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FDA 510(k)

SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER

K-Number: K001995 · 2000-09-08

ApplicantQrs Diagnostic, LLC
Decision Date2000-09-08
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Qrs Diagnostic, LLC. It received FDA 510(k) clearance on 2000-09-08 under 510(k) number K001995. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER?

SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER is a medical device that received FDA 510(k) clearance on 2000-09-08. The listed applicant is Qrs Diagnostic, LLC. The 510(k) number is K001995.

When did SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER receive FDA 510(k) clearance?

SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER received FDA 510(k) clearance on 2000-09-08, under 510(k) number K001995.

Who is the listed applicant for SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER?

The FDA 510(k) record lists Qrs Diagnostic, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER?

The FDA product code for SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER is DQA.

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Other records listing Qrs Diagnostic, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K083749CARDIOVIEW32 REVIEW MODULEK073630MODIFICATION TO: BPCARD, MODEL Z-7000-0700K031964BPCARDK030535EKGCARD SYSTEMK001278SENSAIRE DIAGNOSTIC SPIROMETERK973138SPIROCARD

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Related Devices (Code: DQA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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